Sodium Valproate for Injection

The mechanism of anti-epileptic action has not been elucidated, but it may be related to the increase in the concentration of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain. Generally, the increase in GABA is achieved by reducing metabolism or reabsorption. In addition, valproic acid acts on the postsynaptic receptor site to simulate or enhance the inhibitory effect of GABA. Its effect on the nerve membrane has not been fully elucidated, but it may directly act on the membrane activity related to potassium conduction.

Main ingredient: Sodium valproate Chemical name: 2-sodium valproate Molecular formula: C8H15NaO2 Molecular weight: 166.20

This product is white powder or freeze-dried cake.

This product is mainly used for simple or complex absence seizures, myoclonic seizures and generalized tonic-clonic seizures (grand mal seizures) of epilepsy. It also has a certain effect on complex partial seizures.

Intravenous injection: Adults, 400 mg intravenously, twice a day for status epilepticus.

1. Rare reactions include: (1) Allergic rash. (2) Thrombocytopenia or inhibition of platelet aggregation leading to abnormal bleeding or ecchymosis. (3) Hepatotoxicity with yellowing of eyes and skin. 2. The following reactions should be noted if they persist: (1) The more common ones include: diarrhea, indigestion, nausea or vomiting, gastrointestinal spasm, and changes in menstrual cycle. (2) The less common or rare ones include: constipation, drowsiness, generally mild and transient hair loss, dizziness, fatigue, headache, ataxia, abnormal excitement, restlessness, and irritability.

Contraindicated in patients with liver disease or significant liver impairment.

Precautions for children: See other items, or follow the doctor's advice. Precautions for pregnancy and lactation: Pregnancy 1. Dangers related to epilepsy and anti-epileptic drugs. The overall rate of malformation in the offspring of women with epilepsy who take any anti-epileptic drug is 2 to 3 times higher than that of the normal population (3%). Although there are more reports of children with infant malformations caused by the combined use of multiple drugs, the teratogenic effect of each drug has not yet been established. The most common malformations are cleft lip and cardiovascular malformations; sudden cessation of anti-epileptic drug treatment will worsen the mother's condition, which is also harmful to the fetus. 2. Dangers related to sodium valproate Animals: Experiments have shown that it has teratogenic effects on mice, rats and rabbits. Humans: The teratogenic risk of taking sodium valproate in the first 3 months of pregnancy for women with epilepsy is the same as taking other anti-epileptic drugs, but sodium valproate can cause neural tube defects, such as meningocele and spina bifida. These malformations can be diagnosed before birth, and their incidence is about 1%. There are also a few reports of facial deformities and limb abnormalities, but the incidence rate is not yet accurate. Opinions on the above reports: ① Women with epilepsy treated with sodium valproate are not recommended to get pregnant; ② If you plan to get pregnant, you should weigh the anti-epileptic treatment plan again; ③ During pregnancy, if sodium valproate anti-epileptic treatment is effective, it should not be discontinued. It is recommended to use the minimum effective dose and take it several times a day. ④ Specific prenatal monitoring should be carried out in a specialist center at the beginning of pregnancy to detect possible neural tube defects or malformations as early as possible. 3. There are individual reports of neonates that the use of sodium valproate by mothers during pregnancy can cause neonatal hemorrhagic syndrome, but this disease is different from the bleeding symptoms of vitamin K deficiency caused by phenobarbital and enzyme inducers. The bleeding caused by sodium valproate is not due to vitamin K deficiency, but is related to hypofibrinemia. Platelet count, fibrinogen and clotting time (APTT: partial prothrombin activity time) should be performed before the mother gives birth. If these tests are normal, neonatal coagulation abnormalities can be ruled out. Invasive delivery increases the risk of bleeding. Platelet count, fibrinogen and clotting time (APTT) tests should also be performed when the newborn is born. The secretion of sodium valproate in human milk is very small, about 1% to 10% of the plasma concentration. No clinical abnormalities were found in the follow-up of breast-fed newborns. Precautions for the elderly: See other items or follow the doctor's advice.

1 This product can inhibit the metabolism of phenytoin sodium, phenobarbital, primidone, and clonazepam, which can easily lead to their poisoning. Therefore, the dosage should be adjusted when used in combination. 2 Drinking alcohol can aggravate the sedative effect. 3 When general anesthetics or central nervous system depressants are used in combination with valproic acid, the clinical effect of the former may be more obvious. 4 When used in combination with anticoagulants such as warfarin or heparin, as well as thrombolytic drugs, the risk of bleeding increases. 5 When used in combination with aspirin or dipyridamole, the bleeding time may be prolonged due to reduced platelet aggregation. 6 When used in combination with carbamazepine, the induction of liver enzymes may accelerate drug metabolism, which may reduce the blood concentration and half-life of both drugs. Therefore, the blood concentration must be monitored to determine whether the dosage needs to be adjusted. 7. When used in combination with haloperidol, loxapine, maprotiline, monoamine oxidase inhibitors, phenothiazines, thioxanthenes and tricyclic antidepressants, it can increase the inhibition of the central nervous system, lower the convulsion threshold and the effect of valproic acid, and the dosage must be adjusted in time to control seizures.

Seal and store in a dry place below 25℃.

0.4g

24 months

Sichuan Credit Pharmaceutical Co., Ltd.

• Founded in:

  2000-04-20

• Address:

  Pharmaceutical Industrial Park, Luzhou National High-tech Zone, Sichuan Province

• Tax NO.:

  915105217144041624

• Registered Funds:

  27.214286 million yuan

• Website:

  Log in to view

• Email:

  Log in to view